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dc.contributor.authorCox, Rebecca Janeen_US
dc.contributor.authorMajor, Dianeen_US
dc.contributor.authorPedersen, Gabriel Kristianen_US
dc.contributor.authorPathirana, Rishien_US
dc.contributor.authorHöschler, Katjaen_US
dc.contributor.authorGuilfoyle, Kateen_US
dc.contributor.authorRoseby, Sarahen_US
dc.contributor.authorBredholt, Geiren_US
dc.contributor.authorAssmus, Jörgen_US
dc.contributor.authorBreakwell, Lucyen_US
dc.contributor.authorCampitelli, Lauraen_US
dc.contributor.authorSjursen, Haakonen_US
dc.date.accessioned2016-01-11T13:52:02Z
dc.date.available2016-01-11T13:52:02Z
dc.date.issued2015-07-06
dc.PublishedPLoS ONE 2015, 10:e0131652(7)eng
dc.identifier.issn1932-6203
dc.identifier.urihttps://hdl.handle.net/1956/10924
dc.description.abstractBackground and Methods: Highly pathogenic avian influenza (HPAI) viruses constitute a pandemic threat and the development of effective vaccines is a global priority. Sixty adults were recruited into a randomized clinical trial and were intramuscularly immunized with two virosomal vaccine H5N1 (NIBRG-14) doses (21 days apart) of 30μg HA alone or 1.5, 7.5 or 30μg HA adjuvanted with Matrix M. The kinetics and longevity of the serological responses against NIBRG-14 were determined by haemagglutination inhibition (HI), single radial haemolysis (SRH), microneutralization (MN) and ELISA assays. The cross-H5 clade responses in sera were determined by HI and the antibody-secreting (ASC) cell ELISPOT assays. The protective efficacy of the vaccine against homologous HPAI challenge was evaluated in ferrets. Results: The serological responses against the homologous and cross-reactive strains generally peaked one week after the second dose, and formulation with Matrix M augmented the responses. The NIBRG-14-specific seroprotection rates fell significantly by six months and were low against cross-reactive strains although the adjuvant appeared to prolong the longevity of the protective responses in some subjects. By 12 months post-vaccination, nearly all vaccinees had NIBRG-14-specific antibody titres below the protective thresholds. The Matrix M adjuvant was shown to greatly improve ASC and serum IgG responses following vaccination. In a HPAI ferret challenge model, the vaccine protected the animals from febrile responses, severe weight loss and local and systemic spread of the virus. Conclusion: Our findings show that the Matrix M-adjuvanted virosomal H5N1 vaccine is a promising pre-pandemic vaccine candidate.en_US
dc.language.isoengeng
dc.publisherPLOSeng
dc.rightsAttribution CC BY 4.0eng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0eng
dc.subjectVaccineseng
dc.subjectH5N1eng
dc.titleMatrix M H5N1 vaccine induces cross-H5 clade humoral immune responses in a randomized clinical trial and provides protection from highly pathogenic influenza challenge in ferretsen_US
dc.typePeer reviewed
dc.typeJournal article
dc.date.updated2015-12-22T10:38:18Z
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright 2015 Cox et al.
dc.identifier.doihttps://doi.org/10.1371/journal.pone.0131652
dc.identifier.cristin1283979
dc.relation.projectNorges forskningsråd: 220670
dc.subject.nsiVDP::Medisinske Fag: 700en_US


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Attribution CC BY 4.0
Except where otherwise noted, this item's license is described as Attribution CC BY 4.0